Field performance of three Ebola rapid diagnostic tests used during the 2018–20 outbreak in the eastern Democratic Republic of the Congo: a retrospective, multicentre observational study

Rapid diagnostic tests versus RT–PCR for Ebola virus infections: a systematic review and meta-analysis

“…Nevertheless, this explanation is unlikely since a newly published study conducted on patients also demonstrated that the sensitivity of three rapid tests (QuickNavi-Ebola, OraQuick Ebola Rapid Antigen Test (OraSure Technologies, Bethlehem, USA) and EBOLA Ag K -SET rapid test) varied, from 40% to 87%. 43 Thus, for Ebola rapid tests with potential acceptable sensitivity, well designed clinical studies with larger sample sizes are necessary for an adequate assessment of their current performance.…”

Ebola-Detect: A differential serodiagnostic assay for Ebola virus infections and surveillance in the presence of vaccine-induced antibodies

“…Both the two peptide-mix (EBOV-Detect-1) and four peptide-mix (EBOV-Detect-2) assays show >95% sensitivity and >94% specificity, similar or superior to other published EBOV serodiagnostic assays. 1 , 4 , 19 , 29 The high specificity of EBOV-Detect-1 and EBOV-Detect-2 for vaccinated individuals compared with current GP-based serodiagnostic assays would ensure that very few EBO-vaccinated individuals will be diagnosed false positives. The false-seropositive diagnosis of EBOV vaccinated but uninfected individuals can be further mitigated by testing in a secondary confirmatory assay like a western blot assay, similar to the two-pronged testing approach for the participants in HIV vaccine clinical trials.…”

“…However, their ability to detect EBOV infection has been limited with sensitivity ranging between 38 to 87% that does not achieve the desired sensitivity and specificity per the World Health Organization (WHO) target product profile. 4 While PCR-based detection tests have routinely been used during the EBOV epidemics, 5 however, they require significant infrastructure and with operational and technical expertise, thus complicating deployment in resource-limited settings. 3 , 6 , 7 A simple ELISA or another serodiagnostic assays for the detection of EBOV-infection induced antibodies offers many advantages, as they are rapid and can be performed with limited resources.…”

Resurgence of Ebola Virus: Transmission, Pathogenesis, Prevention and Cure

“…The findings indicated that the three RDTs evaluated did not meet the WHO target product profile's requirements for sensitivity and specificity. In spite of the fact that they are unable to triage and exclude Ebola virus infection among clinical suspicions, RDTs can nevertheless help in categorizing persons with suspected Ebola virus disease into low-risk and high-risk groups while waiting for GeneXpert Ebola assay reference testing 32 .…”